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Elastography in Thyroid Nodules

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01102127
First Posted: April 13, 2010
Last Update Posted: May 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Castilla-León Health Service
  Purpose
Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.

Condition Intervention
Nodular Goiter Thyroid Cancer Device: Elastography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.

Resource links provided by NLM:


Further study details as provided by Castilla-León Health Service:

Primary Outcome Measures:
  • Diagnostic accuracy of elastography for thyroid cancer [ Time Frame: 1 day ]
    Sensitivity, specifity, predictive values


Biospecimen Retention:   Samples Without DNA
Thyroid cells

Enrollment: 128
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Goiter
Patients with nodular goiter
Device: Elastography
Performance of US, elastography and FNA.

Detailed Description:

Aims:

Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population.

Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA.

Patient selection:

Inclusion criteria:

  • Age > 18 yr.
  • Recruitment in Endocrinology Clinics.
  • Nodular goiter.
  • Multinodular goiter with dominant nodule > 1 cm.

Exclusion criteria:

  • Toxic nodules
  • Non-accessible nodules to US or FNA
  • Cystic nodules
  • Nodules with calcifications in egg rind
  • Contraindication for FNA
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General population with nodular goiter.
Criteria

Inclusion Criteria:

  • Age > 18 yr.
  • Recruitment in Endocrinology surgery.
  • Nodular goiter.
  • Multinodular goiter with dominant nodule > 1 cm.

Exclusion Criteria:

  • Toxic nodules
  • Non-accessible nodules to US or FNA
  • Cystic nodules
  • Nodules with calcifications in egg rind
  • Contraindication of FNA
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102127


Locations
Spain
Complejo Asistencial de León
León, Spain, 24008
Sponsors and Collaborators
Castilla-León Health Service
Investigators
Principal Investigator: Alfonso Vidal-Casariego, MD Complejo Asistencial de León
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alfonso Vidal-Casariego, Complejo Asistencial de León
ClinicalTrials.gov Identifier: NCT01102127     History of Changes
Other Study ID Numbers: TNUS122009
First Submitted: April 12, 2010
First Posted: April 13, 2010
Last Update Posted: May 25, 2011
Last Verified: April 2011

Keywords provided by Castilla-León Health Service:
elastography
thyroid nodule
fine-needle aspiration

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Thyroid Nodule
Goiter, Nodular
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Goiter